Kornimate/medical-research-clean huggingface dataset:
atrial fibrillation after pfo closure

Conditions: Stroke

Summary: an increased risk of atrial fibrillation (af) after patent foramen ovale (pfo) closure was observed in randomized trials but systematic screening of af was not performed in these studies. purpose: the objective of this study was to evaluate incidence of af in patients who underwent percutaneous pfo closure with serial 24-hours ambulatory ecg (aecg) monitoring during 6 months follow-up. primary endpoint was incidence of af on ecg monitoring. secondary endpoints were clinical outcomes (symptoms, hospitalization from cardiovascular causes, ischemic stroke, or bleeding) up to 6 month follow-up.

this is a prospective, bicentric, observational cohort study which will be performed in university hospital center of montpellier and nîmes the study will include all consecutive patients, admitted for a percutaneous pfo closure after an ischemic stroke (is) or a transient ischemic attack (tia) of cryptogenic origin, or after the occurrence of a decompression illness during scuba diving. patients eligible for the closure of a fop in prevention of the recurrence of stroke or tia of cryptogenic origin, was systematically evaluated for exclusion of supraventricular arrhythmia in accordance with international recommendations. this evaluation included a 12-lead ecg as well as an extended electrocardiographic monitoring lasting more than or equal to 24 hours (most frequently, performing a 72-hour ecg holter). all patients previously has a transesophageal ultrasound (tee) allowing to retain the diagnosis of pfo, to assess the presence or not of an atrial septum aneurysm (asa) associated with pfo and to quantify the right to left shunt thanks to a contrast test potentiated by a valsalva maneuver. exclusion criteria included interatrial defect with left to right and others indications for pfo closure that cryptogenic stroke or decompression illness. indication of pfo closure is always validated by a cardio neurological team. the primary objective of the study was incidence of af defined as an irregular rhythm without discernible p waves lasting at least 30 seconds on ecg monitoring during the 6-month follow-up. the secondary objectives were to evaluate the characteristics of the supra-ventricular arrhythmias (delay in onset, duration, recurrent nature), incidence of others arrhythmia, symptoms, and prognostic implications of af (hospitalization , need of curative anticoagulation, need for cardioversion and occurrence of neurological accident documented by imagery (ischemic stroke or tia). the investigators also evaluated risk factors for occurrence of arrhythmia. a total of 100 patients included during 1 year is expected

Eligibility criteria:
inclusion criteria: * men or women over the age of 18 to 60 * benefiting from the closure of the fop percutaneously after a cryptogenic ischemic stroke or a tia (indication validated during a multidisciplinary meeting with neurologists and cardiologists) exclusion criteria: * inability to perform a 24h ecg holter * pregnant or lactating women * vulnerable people

Keywords: cryptogenic
reversal of general anesthesia with methylphenidate

Conditions: Post Operative Cognitive Dysfunction; Emergence From Anesthesia

Summary: the aim of this study is to investigate whether methylphenidate (ritalin) can actively induce emergence from general anesthesia in patients having a pancreaticoduodenectomy (whipple procedure), a pancreatectomy, or a prostatectomy.


Eligibility criteria:
inclusion criteria: * age 18-75 years * american society of anesthesiologists classification 1 or 2 * scheduled to undergo a pancreaticoduodenectomy or distal pancreatectomy at massachusetts general hospital exclusion criteria: * american society of anesthesiologists physical status classification of 3 or beyond.
efficacy and safety of ceftaroline versus linezolid in subjects with complicated skin and skin structure infections

Conditions: Bacterial Infection

Summary: the purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults.

the purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin and skin structure infections in adults. the primary focus is bacterial infection.

Eligibility criteria:
inclusion criteria: * complicated skin and skin structure infection (csssi) * require initial hospitalization, or treatment in an emergency room or urgent care setting exclusion criteria: * hypersensitivity or allergic reaction to any ß-lactam, ceftaroline, linezolid, aztreonam, or to their components * concomitant use of adrenergic or serotonergic agent * uncomplicated skin and skin structure infection * concomitant therapy with any drug known to exhibit a contraindicated drug-drug interaction * more than 24 hours of treatment with an antimicrobial within 96 hours before randomization * known or suspected endocarditis, osteomyelitis, or septic arthritis * severely impaired renal function * evidence of significant hepatic, hematologic, or immunologic disease

Keywords: complicated skin and skin structure infections linezolid ceftaroline clinical response microbiological response cellulitis abscess wound infection deeper soft tissue significant surgical intervention gram-positive bacterial infection gram-negative bacterial infection bacterial infection cephalosporin broad-spectrum activity
genetic mutation in epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer; Nucleotide Variant; Copy Number Variation; Insertion-deletion Variation; Genomic Structural Variation; Total Mutation Burden; Microsatellite Instability; PD-1; PD-L1

Summary: little is known about the characteristics of genetic mutation in a large multi-gene panel in epithelial ovarian cancer. this study is to explore the targeted genetic mutations via a multi-gene panel, which consists of more than 500 hundred genes. the mutation characteristics are to be revealed in single nucleotide variants, copy number variations, insertion-deletion variations, and genomic structural variations. the total mutation burden (tmb) will be calculated. the status of microsatellite instability, expression of pd-1 and pd-l1 antibodies are also tested. these findings will be studies in association with the patients' prognosis and sensitivity to platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * pathology confirmed of recurrent cervical adenocarcinoma, squamous carcinoma or adenosquamous carcinoma * with available materials for analysis * with detailed clinicopathological information * given consent to participate the trial exclusion criteria: * not meeting all of the inclusion criteria
vitamin e δ-tocotrienol (vedt) single dose in healthy subjects

Conditions: Pancreatic Cancer

Summary: this is a phase 1, open-label, non-randomized, dose-finding, study of vitamin e δ-tocotrienol in subjects with resectable pancreatic tumors.

vitamin e tocotrienols have been shown to exhibit cancer-preventive activities in preclinical studies. vitamin e tocotrienols are composed of α-, β-, δ-, and γ-tocotrienols. the investigators preclinical studies indicate that δ-tocotrienol possesses the most potent antitumor activity against pancreatic cancer. it is believed that this micronutrient may have a role in the prevention of pancreatic cancer in healthy participants who are at increased risk of developing the disease.

Eligibility criteria:
inclusion criteria: * the participant is ≥ 18 years old * the participant has an eastern cooperative oncology group (ecog) performance status of ≤ 2. * the participant has adequate organ function as follows: * serum creatinine ≤ 1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min. * bilirubin ≤ the institutional upper limits of normal (uln) * alanine aminotransferase (alt) and aspartate aminotransferase (ast) to be within institutional normal range. * absolute neutrophil count (anc) ≥ 1000mm³ * platelet count ≥ 100,000/mm³ * the participant has the capability of understanding the informed consent document and has signed the informed consent document. * sexually active participants (male and female) must use medically acceptable methods of contraception during the course of the study. * female participants of childbearing potential must have a negative pregnancy test at screening. * able to understand and comply with the requirements of the protocol. exclusion criteria: * the participant is receiving investigational therapy (other than the investigational therapy under study). * the participant has received investigational therapy within 30 days prior to first dose of study drug. * patients who are unable to swallow capsules. * patients with prior malignancies, other than squamous or basal cell carcinomas, unless disease free for ≥ 5 years. * the participant has had prior major surgery within 30 days prior to first dose of study drug. * the participant has active infection or fever \>38.5c within 3 days prior to first dose of study drug. * the participant has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * the participant is unable or unwilling to stop taking vitamins, herbal remedies, or nonprescription medications. * the participant is pregnant or breastfeeding. * the participant is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.

Keywords: prevention pancreas
treatment with low-dose cytarabine in elderly patients (age 70 years or older) with acute myeloid leukemia: a single institution experience.

Conditions: Acute Myeloid Leukemia

Summary: the treatment of very elderly patients (≥70 years) with acute myeloid leukemia remains controversial. although the outcome in younger adults has improved because of cytarabine- and anthracycline-based chemotherapy with advanced supportive care and introduction of hematopoietic stem cell transplantation, the benefit associated with standard intensive chemotherapy in older patients remain debatable. life expectancy in elderly patients is a function of age, disability and comorbidity, performance score, along with leukemia characteristics such as genetic alterations or white blood cell count at diagnosis 'older' patients are generally considered those aged 60 years or older. intensive chemotherapy delivered to the very elderly with aml (patients _70 years of age), may not be beneficial to most and could be harmful to some. however, these patients are often referred to as 'unfit' or ineligible for intensive remission induction therapy. in daily practice, the final decision to treat intensively or not is made by the treating hematologist on a case by case basis according to patient's age, cytogenetics, performance score, concomitant diseases and type of aml (de novo or secondary). in older patients considered 'unfit' for intensive treatment, ld-arac has been demonstrated to be more beneficial than best supportive care and hydroxyurea. the recent availability of new drugs that may have an improved side effect profile and in some cases bioavailability may offer future improvement for this patient population. the efficacy of hypomethylating agents has been studied in older aml patients with conflicting results. recent publications refined prognostic information, which not only optimize existing treatments but also could lead to the development of additional targeted therapeutic approaches. in this study, the investigators focus on patients with aml (_20% blasts) aged 70 or older seen in our institution over a 14-year period. the objectives of the analysis are to describe the demographic, clinical and biological characteristics of this population and to evaluate how these characteristics and the treatment chosen affect


Eligibility criteria:
inclusion criteria: * have a diagnosis of aml according to world health organization (who) classification * are at least 70 years of age exclusion criteria: - patients with m3 aml of fab classification (apl, acute promyelocytic leukemia)

Keywords: chemotherapy, low-intensity therapy, elderly, prognosis,
comparing superficial vs. deep local anesthetic infiltration to improve patient experience during carpal tunnel release

Conditions: Carpal Tunnel; Carpal Tunnel Syndrome

Summary: hypothesis: when comparing superficial infiltration of local anesthetic to superficial and deep infiltration of local anesthetic in the setting of carpal tunnel release, the null hypothesis is that there will be no significant difference between the two techniques. background and study rationale: carpal tunnel syndrome is a very common clinical problem with significant patient burden that can be reliably treated with surgical carpal tunnel release. to minimize operating room time burdens and to improve patient recovery time, this procedure is generally performed with the patient wide awake using local anesthetic. while the majority of patients are able to tolerate this type of procedure, there is always a possibility of some discomfort or pain experienced during the procedure. the investigators would like to compare two local anesthetic infiltration techniques to determine which is best to provide the least amount of pain or discomfort during a carpal tunnel release. the two methods are subcutaneous infiltration alone (superficial) and subcutaneous infiltration with infiltration into the carpal tunnel (deep). research design: this study design is a prospective randomized control trial. methodology: patients will be recruited and randomized on the morning of their surgery to undergo either superficial or superficial and deep local anesthetic infiltration using 10cc of 1% lidocaine with epinephrine buffered with 8.4% sodium bicarbonate. they will be blinded as to which group they are in. participants will complete the boston carpal tunnel questionnaire as a baseline for comparison as well as a brief questionnaire on demographics. after the procedure, participants will complete a short questionnaire about any pain experienced during the administration of the local anesthetic and during the procedure. presence and intensity of pain during the procedure are the primary outcome of this study. secondary outcomes include pain rating at 2, 8, and 24 hours post-procedure and a follow up boston carpal tunnel questionnaire score at 3 months. the surgeon will also make note whether there is any visible evidence of damage to the median nerve from deep infiltration at the time of surgery. statistical analysis: the two groups (superficial vs. deep) will be compared directly for each of the outcomes listed in the methodology.


Eligibility criteria:
inclusion criteria: * \> 18 years of age * undergoing carpal tunnel release exclusion criteria: * patients undergoing repeat carpal tunnel release * patients undergoing simultaneous procedures for other hand/wrist pathology at the time of carpal tunnel release (i.e. trigger finger release, dupuytren's, etc.) * patients with a history of rheumatoid arthritis or a history or previous trauma or surgery to the local area (i.e. distal radius fracture) * patients who lack the capacity to provide informed consent or understand the nature of the project

Keywords: local anesthetic walant
ultrasound-guided anterior hydrodilatation in shoulder adhesive capsulitis

Conditions: Shoulder Capsulitis

Summary: a prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach.

patients was randomized into two equal groups. group i received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group ii received the same ultrasound-guided hydrodilatation via anterior rotator interval approach. both groups received guided stretching exercises for 3 months after injection. baseline and 3 months evaluation of pain by visual analogue scale (vas), shoulder pain and disability index (spadi), and range of motion (rom) had been recorded for all patients. a statistical power analysis was performed after sample size estimation, based on data from the current study (n = 60), comparing group i to group ii. qualitative data was expressed as numbers and percentages, and chi-squared test, quantitative data were expressed as mean and standard deviation.

Eligibility criteria:
inclusion criteria: * patients aged 35 to 60 years, * patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months * patients who had restriction of passive motion. exclusion criteria: * patients with previous trauma, * patients with neurological * patients with endocrinal diseases * patients with shoulder tumor * patients with arthritis * people who had received intra-articular shoulder injection within the last 6 months. * patients with tendon tear
the tolerability, pharmacokinetics and pharmacodynamics study of hec110114 tablets in hcv-infected subjects

Conditions: Chronic Hepatitis C

Summary: a phase ib/iia, single center, randomized, open, sofosbuvir-controlled, multiple ascending dose study to access the tolerability，pharmacokinetics and pharmacodynamics of hec110114 tablets in hcv-infected subjects

a total of 24 evaluable patients will be enrolled in this study. the study randomly divided into three dose groups and hec110114 tablets planned dose levels are 600, 800, and 1200 mg, sofosbuvir tablets planned dose levels are 400 mg .

Eligibility criteria:
inclusion criteria: * sign the informed consent form before the trial and fully understand the contents of the trial, the process and possible adverse reactions; * be able to complete the study according to the trail protocol; * subjects (including partners) have no pregnancy plan within six months after the last dose of study drug and voluntarily take effective contraceptive measures; * male subjects and must be 18 to 65 years of age inclusive; * have a body mass index (bmi) between 18 and 30 kg/m2 inclusive, and a body weight ≥50 kg for males and ≥45 kg for females; * no previous treatment with any direct-acting antiviral (daa) drugs for hcv, such as simeprevir, sofosbuvir, daclatasvir etc; * hcv rna ≥10\*5 iu/ml at screening (roche cobas taqman); * chronic genotype 1-6 hcv infection, multiple genotypes, subtype unidentifiable or others ; * serum alt ≤5 times uln. exclusion criteria: * allergies constitution ( multiple drug and food allergies); * history of alcohol abuse (14 units of alcohol per week: 1 unit = 285 ml of beer, or 25 ml of spirits or 100 ml of wine); * donation or loss of blood over 450 ml within 3 months prior to screening; * history of any non-hcv liver diseases, including but not limited to hemochromatosis, primary biliary cirrhosis, wilson's disease, autoimmune hepatitis, drug or alcoholic hepatitis, non-alcoholic steatohepatitis, etc; * 12-lead ecg with clinically significant; * pregnant or lactating women; * creatinine clearance \< 60 ml/min; * subjects deemed unsuitable by the investigator for any other reason.
feasibility study of a community pilot project for the prevention of alzheimer's disease: the ketohome study.

Conditions: Alzheimer Disease; Glucose Metabolism

Summary: the purpose of this study is to assess whether it is possible to carry out a research project with a nutritional intervention in senior's residence. life in a small community is very different and above all unique, which could be an asset in a research setting.

to ensure its functioning, the brain needs a lot of energy. however, during aging, it has difficulty properly using its main fuel, sugar. the brain then becomes "starved". this energy deficit is part of the vicious circle leading to memory problems. the brain, like a hybrid car, can run on two fuels, sugar and ketones. providing alternative fuel to the brain, in the form of ketones, and thus offsetting the energy it needs, could improve its functioning and help prevent or improve memory problems. there are several ways to increase ketones in our body such as certain dietary oils, natural health products, physical activity or certain diets. reducing the amount of sugar in our diet is also a strategy that can increase ketones. a low-sugar diet is already widely used in the prevention of several important diseases, including type 2 diabetes and even alzheimer's disease. this study will assess the feasibility of a community intervention project in a seniors' residence with the eventual overall objective of slowing the progression or onset of ad and related health indicators, through a dietary modification. this feasibility study will last 6 months. the basic characteristics of interested participants will be collected. the global spheres of evaluation are the following: metabolic profile, cognition, quality of life and nutritional status. glucose measurements will be taken continuously via a sensor over two weeks during the project.

Eligibility criteria:
inclusion criteria: * older men or women resident of grace village and resident of vü; * understand, read and write french or english; * possess sufficient visual and auditory acuity to pass the cognitive tests. exclusion criteria: * the minimum possible criteria ensuring the safety of voluntary participants. the family doctor will need to confirm eligibility. * body mass index \< 22 * malnutrition. * high risk of hypoglycaemia * moderate to severe digestive diseases that can be aggravated by dietary changes * severe dysphagia * supplementation with mct oil, ketone salts, ketone ester, adherence to the ketogenic diet, intermittent fasting, or other diet or supplements that may significantly increase ketones; * participation in other intervention research projects on nutrition or aimed at metabolic change simultaneously.

Keywords: nutritional intervention glucose monitoring reduced carb diet energy metabolism ketones
photoscreening for retinoblastoma

Conditions: Retinoblastoma

Summary: retinoblastoma is the most common pediatric eye malignancy and manifests between 1 and 5 years of age. the tumor is most often diagnosed by leukocoria ( white reflex in the pupil). there is often a significant delay in diagnosis and early diagnosis enables good life prognosis and better vision outcome.there is currently not a standardized screening protocol for detection of retinoblastoma. vision screening methods are recommended for children 3-5 years of age. the investigators are attempting to use instrument based screening started from birth to detect leukocoria.


Eligibility criteria:
inclusion criteria: * age birth to 10 years * informed consent given by parent or legal guardian exclusion criteria: * none